NCT04761263

Brief Summary

Statement of the problem: Does task-oriented circuit training have an effect on kinematic parameters of gait, pelvic symmetry and trunk endurance in children with hemiplegic CP? Purpose of the study: This study aims to:

  • Investigate the effect of exercise-based task-oriented circuit training on gait kinematics including (Stride length, step length, cadence, walking speed, ankle dorsiflexion angle in initial contact, knee extension angle in midstance and hip extension angle in terminal stance) in children with hemiplegic CP.
  • Determine the effect of task-oriented circuit training on pelvic symmetry including (Anterior and lateral pelvic tilting) in children with hemiplegic CP.
  • Examine the effect of task-oriented circuit training on trunk endurance including (prone plank test, timed partial curl up test, front abdominal power test and unilateral supine bridge test) in children with hemiplegic CP.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 7, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 18, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

1 year

First QC Date

February 9, 2021

Last Update Submit

March 18, 2022

Conditions

Keywords

hemiplegic cerebral palsy

Outcome Measures

Primary Outcomes (4)

  • Assessing the change in Angular displacement of joints during gait cycle

    assessment via using 2D gait analysis by Kinovea software in order to measure change in angular displacement of joints during gait cycle including: angle of ankle dorsiflexion at initial contact, angle of knee extension at midstance and angle of hip extension during terminal stance. All of these measurements have the same unit which is (angle in degrees)

    at baseline and after 3 months of intervention

  • Assessing the change in Pelvic symmetry

    by using palpation meter inclinometer to measure the change in anterior and lateral pelvic tilting angles in degrees

    at baseline and after 3 months of intervention

  • Assessing the change in spatial parameters of gait

    assessment via using 2D gait analysis by Kinovea software in order to measure change in step length and stride length in centimeters.

    at baseline and after 3 months of intervention

  • Assessing the change in Temporal parameters of gait

    assessment via using 2D gait analysis by Kinovea software in order to measure change in cadence (number of steps/minute) and walking speed (meter/minute)

    at baseline and after 3 months of intervention

Secondary Outcomes (1)

  • Assessing the change in Trunk muscles endurance

    at baseline and after 3 months of intervention

Study Arms (2)

Selected Physical Therapy group

ACTIVE COMPARATOR

will receive a selected physical therapy program for 90 minutes, 3 times/week for 3 successive months.

Other: Selected Physical therapy program

Task-oriented circuit training group

EXPERIMENTAL

Children allocated to the study group will receive the same selected physical therapy program given to the control group for 45 minutes in addition to 45 minutes task-oriented circuit training program. The frequency of the whole program will be three times per week, for three months.

Other: Task-oriented circuit trainingOther: Selected Physical therapy program

Interventions

The task-oriented circuit training program consisted of 14 workstations. Time spent at each station will be 1.5 minutes. The children will complete the activity at one station and move to another station. The whole circuit will be completed in 21 minutes and it will be repeated twice per session with 3 minutes rest interval between the 2 circuits. Children will be encouraged to work as hard as possible at each workstation and will also be given verbal feedback and instructions aimed at improving performance. The progression of the task will be considered according to each child's ability and progressed as tolerated. Progressions include increasing the number of repetitions and increasing complexity of the exercise performed at each workstation, such as the distance reached in standing, reducing the height of the chair during sit-to stand, changing the height of blocks or by increasing speed of movement.

Task-oriented circuit training group

* Facilitation of balance reactions from standing position including; standing on one leg, weight shifting from standing position, stoop and recover from standing, squat from standing and standing on balance board. * Facilitation of counterpoising mechanism through instructing the child to kick ball from standing position as well as catching and throwing ball with his hands. * Gait training activities including: walking using different obstacles (rolls, wedges, stepper) and walking up and down stairs. * Facilitation of protective reaction from standing position by pushing the child in different directions. * Facilitation of rising mechanism through changing position as well as returning back to the original position e.g.: from lying to standing and from sitting to standing. * Strengthening exercises for back and abdominal muscles as well as upper and lower limbs. * Jumping in place and jumping a board.

Selected Physical Therapy groupTask-oriented circuit training group

Eligibility Criteria

Age7 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Their age will be ranged from 7-10 years.
  • Their motor function will be at level I and II according to Gross Motor Function Classification System GMFCS (Palisano et al., 2008).
  • The degree of spasticity will range from mild to moderate according to Modified Ashworth Scale (Bohannon and Smith, 1987).
  • They will be able to follow instructions during evaluation and treatment.

You may not qualify if:

  • Children will be excluded from the study if they have:
  • Other types of cerebral palsy.
  • Cardiovascular or respiratory disorders.
  • Botulinium muscular injection in the last 6 months
  • Surgical interference in lower limbs and/or spine.
  • Muscloskeletal problems or fixed deformities in the spine and/or lower extremities.
  • seizures.
  • Visual or hearing impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient clinic, Faculty of Physical Therapy, Cairo University

Cairo, 34518, Egypt

Location

Related Publications (1)

  • El-Sayed MS, Kilany A, El Shemy SA. Efficacy of Task-Oriented Circuit Training on Gait Kinematics, Pelvic Symmetry and Trunk Endurance in Children with Hemiplegia: A Randomized Controlled Trial. J Musculoskelet Neuronal Interact. 2025 Mar 1;25(1):36-46. doi: 10.22540/JMNI-25-036.

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Mohamed El-Sayed, Assistant lecturer

    Horus University in Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: two different groups received different interventions at the same time
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 9, 2021

First Posted

February 18, 2021

Study Start

February 7, 2021

Primary Completion

February 15, 2022

Study Completion

March 15, 2022

Last Updated

March 22, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations